Novartis
The Sr GPRM works under limited supervision of the regulatory affairs (RA) program lead to develop and implement the global regulatory strategy for program(s) through development, registration and post approval in the assigned region(s). They may act as the RA program lead on programs of limited complexity. The Sr GPRM is a member of the RA sub team and may lead or represent RA in regional or cross-functional teams. They may also act as a subject matter expert and/or assume mentoring role.
Major accountabilities:
Regulatory Strategy
- Provides input to global program regulatory strategy, including regulatory designations & innovative approaches
- May provide global RA leadership for specific part of the program or act as RA program lead for program of limited complexity
- Represents RA or leads in regional RA or cross-functional activities
- Determines requirements and coordinates activities for Health Authority (HA) interactions. May lead HAs meetings together with RA program lead.
- May serve as local HA liaison (e.g., FDA or EMA).
Regulatory Submissions
- Leads planning, preparation and submission of clinical trials.
- Coordinates, plans, and prepares for submission of initial registration and post-approval applications, including authoring of Module 1 documents
Regulatory Excellence and Compliance
- Ensures timely RA input and submission of regulatory compliance and maintenance reports (e.g. aggregate safety reports, annual reports, renewals, etc) across assigned regions
Commitment to Diversity & Inclusion:
We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.
Role Requirements
Education
Bachelors Degree Preferred (Minimum/desirable)
- Science based BS or MS. Advanced degree (e.g., MD, PhD, PharmD, regulatory) preferred
- Advanced understanding of pharmaceutical development, clinical trials, analysis and interpretation of scientific data
- Awareness of post-marketing/brand optimization strategies and commercial aspects.
- ≥4 years involvement in regulatory and pharmaceutical development spanning activities in Phases I-IV in 1 or more major region.
- Experience in leading cross-functional teams
- Strong collaboration, communication influencing and problem solving skills.
- Organizational awareness (e.g., interrelationship of departments, business priorities)
Why Novartis?
766 million lives were touched by Novartis medicines in 2021, and while we’re proud of this, we know there is so much more we could do to help improve and extend people’s lives.
We believe new insights, perspectives and ground-breaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working.
We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. And we can reinvent what’s possible, when we collaborate with courage to aggressively and ambitiously tackle the world’s toughest medical challenges. Because the greatest risk in life, is the risk of never trying!
Imagine what you could do here at Novartis!
Division
Development
Business Unit
REG AFFAIRS GDD
Work Location
Basel
Company/Legal Entity
Novartis Pharma AG
Alternative Country 1
United Kingdom
Functional Area
Research & Development
Job Type
Full Time
Employment Type
Regular
Shift Work
No
Early Talent
No
To apply for this job please visit sjobs.brassring.com.